A Randomised Single Centre Study to Compare the Long-term Performance of 4 Designs of the DePuy Ultima LX Stem in Primary Total Hip Replacement

Clinical and Radiographic Evaluation to Compare a Polished and Non-polished Collared Stem and a Polished and Non Polished Collarless Stem in Primary Total Hip Replacement

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00208351

Enrollment

164

Registered

2005-09-21

Start date

1997-05-31

Completion date

2015-03-31

Last updated

2016-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Avascular Necrosis, Collagen Disorder, Congenital Hip Dysplasia, Nonunion of Femoral Fractures, Osteoarthritis, Post-traumatic Arthritis, Slipped Capital Femoral Epiphysis, Traumatic Femoral Fractures

Keywords

Hip, Cemented

Brief summary

The purpose of this study is to compare the performance of 4 designs of the DePuy Ultima LX hip stem in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to one of the 4 designs of the DePuy Ultima LX hip stem and will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.

Interventions

DEVICEUltima LX Collared Stem - Non-Polished/Blasted Finished

A collared non-polished/blasted finished cementless femoral component for use in total hip replacement.

DEVICEUltima LX Collared Stem - Polished Finished

A collared polished finished cementless femoral component for use in total hip replacement.

DEVICEUltima LX Collarless Stem - Non-Polished/Blasted Finished

A collarless non-polished/blasted finished cementless femoral component for use in total hip replacement.

DEVICEUltima LX Collarless Stem - Polished finished

A collarless polished finished cementless femoral component for use in total hip replacement.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to 80 Years

Healthy volunteers

Inclusion criteria

Current indications for primary total hip arthroplasty utilising a cemented femoral component. These include pain, deformity and loss of function which are not responsive to medical treatment

Exclusion criteria

i) Revision Total Hip Arthroplasty ii) Rheumatoid arthritis iii) Age greater than 80 years at time of surgery iv) Age less than 60 years at time of surgery v) Previous hip joint sepsis vi) Obesity vii) Patient likely to remain housebound once rehabilitation is complete

Design outcomes

Primary

Measure	Time frame	Description
Stem movement measured radiographically at 2 years	2yrs post-surgery	Stem movement was measured radiographically by comparing baseline stem position with the stem position 2 years after surgery. If migration was observed to be 5 or more mm, it was considered clinically significant migration.

Secondary

Measure	Time frame	Description
Comparisons of Visual Analog Pain (VAS), 36-Item Short Form Health Survey (SF-36), Satisfaction, Limb Length and stem movement measured radiographically at 5 years.	5yrs post-surgery	The following outcome measures were used; VAS Pain score, SF36 Patient reported outcome, Satisfaction, Limb Length physical examination, and stem movement measured radiographically.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026